Details for New Drug Application (NDA): 212491
NDA 212491 describes CYPROLARA, which is a drug marketed by Quagen and is included in one NDA. It is available from six suppliers. Additional details are available on the CYPROLARA profile page.
The generic ingredient in CYPROLARA is cyproheptadine hydrochloride. There is one drug master file entry for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.
The generic ingredient in CYPROLARA is cyproheptadine hydrochloride. There is one drug master file entry for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.
Summary for 212491
| Tradename: | CYPROLARA |
| Applicant: | Quagen |
| Ingredient: | cyproheptadine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 212491
Suppliers and Packaging for NDA: 212491
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | TABLET;ORAL | 212491 | ANDA | QPharma Inc | 42708-187 | 42708-187-21 | 21 TABLET in 1 BOTTLE, PLASTIC (42708-187-21) |
| CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | TABLET;ORAL | 212491 | ANDA | REMEDYREPACK INC. | 70518-3517 | 70518-3517-0 | 30 TABLET in 1 BLISTER PACK (70518-3517-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Feb 24, 2021 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Oct 2, 2026 | TE: | RLD: | No | |||||
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